ISO 13485 does not spell out the specific measures for device manufacturers to take. However, the certification gets people in the mindset that quality happens at every stage of manufacturing and that ...

Stratasys Direct facility in Tuscon, Arizona, achieves ISO 13485 certification, and is now formally recognized for safety and reliability.

today announced that it has received ISO 13485:2016 certification from the British Standards Institute (BSI). “This ISO certification is a major step in our journey toward delivering high ...

ROSEMONT, IL, USA, 01/06/2020 – Proteintech Group, Inc, the benchmark in antibodies and proteins, announces completion of its ISO 13485 certification for medical devices. With this certification, ...

EDEN PRAIRIE, Minn. & REHOVOT, Israel - Stratasys Ltd. (NASDAQ: NASDAQ:SSYS) has announced that its Stratasys Direct facility in Tucson, Arizona, has received ISO 13485 certification. This standard is ...

ISO 13485 is a stringent, internationally recognized standard that sets the requirements for quality management systems in the medical device industry. To achieve this certification, companies ...